Thursday, March 31, 2005

According to an article in today's Jerusalem Post, American Cancer Society president Dr. John Seffrin told members of the Israel Cancer Association that all those involved in the production and marketing of tobacco products are "terrorists." The article quotes Seffrin as stating that by 2020, "one third of all deaths worldwide will be caused by tobacco and its terrorists." The article states that: "In repeatedly calling the purveyors of tobacco terrorists, Seffrin noted that they knowingly push a product that kills."

The Rest of the Story

Assuming that the article is accurate and Seffrin did in fact call tobacco manufacturers like Philip Morris "terrorists," is it not then egregious that Seffrin's American Cancer Society is standing shoulder-to-shoulder with this "terrorist" group in pushing for legislation (the FDA tobacco bill) that will significantly aid the "terrorist" organization? Is the American Cancer Society not aiding and abetting a "terrorist" group by working with Philip Morris to secure legislation that is highly desired by this company, so much that the company's web site touts how much Philip Morris is "committed" to this legislation and how "diligently" the company is working to promote it?

How hypocritical can a public health organization be? How can you, on the one hand, call Philip Morris a "terrorist" group, and then on the other, work side-by-side with Philip Morris to advance legislation that it dearly wants? Are you not then supporting "terrorism?"

I completely reject any reference to tobacco manufacturers and marketers as "terrorists," and if Dr. Seffrin made this remark (and there is no reason to believe that the Post is not being accurate in its reporting), I think it is inappropriate, irresponsible, and plainly wrong.

Terrorism is defined as "The unlawful or threatened use of force or violence by a person or an organized group against people or property with the intention of intimidating or coercing societies or governments, often for ideological or political reasons." There is nothing that tobacco manufacturers are doing that could even remotely be considered to be terrorism. Their manufacturing and promoting of tobacco products are lawful, they are not using force or violence against people or property, and they certainly do not have an intention of intimidating or coercing societies or governments.

This appears to be yet another example of an inappropriate tactic being used by a public health organization to promote the tobacco control cause. Here, the American Cancer Society is apparently misusing and perhaps abusing the English language to rile up an Israeli audience about the tobacco problem, knowing that terrorism is a problem that has profound emotional significance for this group.

I certainly support efforts to mobilize citizens to take action about the problem of tobacco in our society. But these efforts should be based on some degree of integrity, reasonableness, and appropriateness. To call tobacco manufacturers terrorists is none of these three.

The ends do not justify the means, even in tobacco control. Just because we are working for a noble and important cause does not justify the use of misleading and inappropriate tactics. Comparing tobacco manufacturers to terrorists does a disservice not only to the families of those whose lives have actually been lost due to terrorism, but to the integrity of the tobacco control movement.

Wednesday, March 30, 2005

In a previous post, I commented on what I believe to be an inappropriate omission in the amicus brief submitted by American Legacy Foundation-funded Citizens' Commission to Protect the Truth in the DOJ lawsuit: namely, the failure to disclose that the Citizens' Commission is funded by the Legacy Foundation. I think here it is also worth commenting on the substance of the Commission's argument, leaving aside the issue of whether or not there is an inherent conflict of interest in presentation of the basic argument.

The two basic arguments presented in the brief are that: (1) an appropriate remedy for the tobacco company defendants' violations of the RICO statute is to order them "to fund a public education and youth smoking prevention campaign"; and (2) that "the American Legacy Foundation's truth® campaign should be the organization so funded.

The brief argues that ordering the tobacco companies to fund a public education and youth smoking prevention campaign is an appropriate remedy because it will help prevent and restrain further violations of RICO: "requiring the Defendants to fund independent third-parties' marketing and advertising campaigns, such as the truth® campaign, prevents future violations by affecting the Defendants' future conduct and shifting the focus of the Defendants' future marketing activities. Such a remedy will require the Defendant tobacco companies to fund effective, independent smoking prevention programs, thereby avoiding the type of public misinformation campaign engaged in by the Defendants. Impacting Defendants' conduct by requiring them to fund third-party anti-smoking campaigns is an effective and authorized way both to address the Defendants' RICO violations and to satisfy the requirements set forth by the Circuit Court of Appeals, by aiming to prevent continuing and future violations rather than cure those of the past."

The Rest of the Story

I think that a careful analysis of this argument reveals it to be flawed. The main problem is that the argument incorrectly assumes an either-or scenario for the tobacco company's marketing activities. Either the companies continue their past patterns of deceptive marketing or they fund the Legacy Foundation and change the manner in which they market their products.

But it seems to me that there is another, more likely possibility: that the companies will fund the Legacy Foundation AND continue their past patterns of deceptive marketing. There is nothing that writing a check out to the American Legacy Foundation will do to change the basic marketing practices of the industry. Just because they are told they must pay for a "truth" campaign does not mean that they cannot or will not continue to use deceptive marketing practices to promote the use of their products. In other words, requiring Defendants to fund the truth® campaign will do nothing to deter future RICO violations. I think the argument fails.

Breaking the brief down, the central argument really rests on two basic premises:

(1) "Ordering the tobacco companies to fund an effective, independent smoking prevention campaign will serve precisely the function contemplated by [RICO civil remedies provision] by directing the manner in which Defendants will market their product."

This premise is flawed because having the Defendants write out a check for a third-party anti-smoking campaign does nothing to direct their marketing activities. They can continue to market the product however they wish, including using deceptive techniques to entice youth to smoke, undermining public health efforts to educate the public about the true risks of smoking, and targeting youths in their advertising. They can even directly undermine the anti-smoking campaign in their own marketing if they want to. If anything, the tobacco companies would be freer to continue their deceptive marketing, because they could use the fact that they are funding the truth® campaign to increase their public good will and detract attention from their marketing practices.

(2) "Placing the onus on the tobacco companies to fund a public education and smoking prevention campaign will effect a shift in the tobacco companies' marketing focus and conduct by forcing them to fund effective anti-smoking and smoking prevention advertising by third parties, rather than the current pro-smoking marketing in which the tobacco companies still are currently engaged."

This premise is flawed because forcing the companies to fund a smoking prevention campaign does not require them or entice them in any way to discontinue "the current pro-smoking marketing" in which they are currently engaged. If anything, it would give the companies more of an incentive to aggressively market their product. They would have to be increasingly effective in their "pro-smoking marketing" in order to offset any negative impacts of the independent anti-smoking campaign.

Frankly, the idea that forcing the companies the fund the truth® campaign will put an end to their current pro-smoking marketing or even to the deceptive aspects of their pro-smoking marketing seems to me to be weak at best and uninformed at worst.

Truly, what it sounds like to me is that the American Legacy Foundation and/or its grantee are struggling to come up with a way to get Legacy funded. The argument presented in the amicus brief seems to me to be so flawed that it makes one wonder whether this is more of a thinly-veiled attempt to promote Legacy's funding rather than a serious attempt at offering an important substantive evaluation of the relevant legal issues to the court.

In actually reading the relevant statute, I find it very difficult to imagine how the funding of a third-party anti-smoking campaign would even remotely serve the function contemplated therein: "The district courts of the United States shall have jurisdiction to prevent and restrain violations of section 1962 of this chapter by issuing appropriate orders, including, but not limited to: ordering any person to divest himself of any interest, direct or indirect, in any enterprise; imposing reasonable restrictions on the future activities or investments of any person, including, but not limited to, prohibiting any person from engaging in the same type of endeavor as the enterprise engaged in, the activities of which affect interstate or foreign commerce; or ordering dissolution or reorganization of any enterprise, making due provision for the rights of innocent persons."

The situation would be different if a huge amount of money were involved. Huge punitive damages, whether they take the form of disgorgement of past profits or otherwise, could deter future RICO violations. But this is not the argument being made in the brief, and it is also not a remedy that is likely, unless the Circuit Court panel's decision is overturned.

The situation would also be different if the amicus brief were calling on the judge to impose direct marketing restrictions on the companies. That seems to be much more in line with what section 1964(a) has in mind.

I'm all for the idea of trying to extract whatever damages and remedies we can out of the tobacco companies in the interest of protecting the public's health. But those remedies must fall within the confines of the law. And here, I simply don't think that requiring the tobacco companies to fund the truth® campaign is a remedy that is consistent with 18 U.S.C. section 1964(a).

Monday, March 28, 2005

According to a news article in this week's BMJ, scientists from the German Cancer Research Centre in Heidelberg are calling for a ban on tobacco product additives because they may increase the risk of cancer and may enhance the likelihood of nicotine addiction. The article explains that cigarette additives may be used for a variety of ends, including: (1) improving the taste of cigarettes, and thereby making them more palatable for young smokers; (2) increasing the addictive strength of nicotine within cigarettes; and (3) allowing smokers to take deeper puffs, and thus inhale a greater amount of carcinogenic and toxic substances.

The Rest of the Story

The folly that characterizes the absurd regulatory approach for which U.S. public health organizations (such as the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association) are lobbying is apparently not restricted to this country. While this cancer research center is calling for the removal of additives from cigarettes, it does not appear to be expressing any particular urgency regarding the addictive and carcinogenic potential of the cigarette itself.

This is the public health paradigm at its worst: regulate the ingredients that are added to the cigarettes, but not the addictive and carcinogenic constituents of the cigarette smoke itself. In other words, the baseline toxic qualities of tobacco products are viewed as being acceptable from the standpoint of societal policy, but not so for anything added to the products. As I pointed out with the FDA tobacco legislation now before Congress, health groups are supporting a bill that bans flavorings added to cigarettes, but does not require FDA to do anything about "naturally" present carcinogens and toxins. And the bill requires notification to consumers of any adverse health effects of substances added to cigarettes, but not of any health risks due to constituents "ordinarily present" in the product.

The underlying senselessness of federal regulation of tobacco products is that the product is inherently toxic, addictive, and carcinogenic. It is not the additives and flavorings that are responsible for the addictive, toxic, and carcinogenic effects. It is the cigarette itself. And setting performance standards to eliminate a few of the offenders is not going to address the problem. Nor is banning cigarette additives.

At this point, one may ask: Am I calling for the banning of tobacco products, or for continuation of the status quo regarding these products? The answer is: Neither.

Banning tobacco products altogether is not an acceptable option, especially based on this country's experience with prohibition of alcohol.

Neither is the status quo. However, arguing against FDA regulation of tobacco products as proposed by Philip Morris and the Campaign for Tobacco-Free Kids is not equivalent to arguing for the status quo (as suggested by the Campaign in a March 21 communication to individual tobacco control advocates). Far from it.

Those of us who are attempting to point out the irrationality of the FDA legislation are actually calling for major changes in the practice of tobacco control in this country. Most importantly, we are suggesting that the persistent, relentless, and probably futile efforts of our national organizations that are devoting substantial resources to this cause should be shifted to areas for which there is evidence of an effect on the public's health.

We agree that the status quo - with the most prominent national tobacco control organization making federal regulation a goal beyond all goals, in the context of a Congress that has almost never enacted effective tobacco control legislation and is certainly not going to start now - is completely unacceptable. We know what works in tobacco control - and that's where our resources should be directed.

I have received a number of comments regarding my views that: (1) increasing cigarette taxes to fund non-tobacco-related projects is inappropriate public health policy; and (2) policies that make off-the-job smoking a criterion for employment decisions are generally inappropriate. I therefore thought it might help to explain how I have come to these views.

I am in the field of tobacco control because as a physician, I view this as the way in which I can work to promote the best interests of the patient. I entered tobacco control because such a large number of my patients were smokers and it became clear that preventing smoking and encouraging smoking cessation on a population-level were the most important goal I could pursue. I also spent two years working in a methadone maintenance clinic and observed the difficulty my clients had overcoming their addiction to cigarettes, which was every bit as strong as their addiction to heroin, cocaine, alcohol, or other drugs. Thus, from my background and experience, I view smokers not as the problem, but as the patients or clients who I am trying to serve through my public health practice.

Now the types of policies that one supports may be different if one views one's role as helping patients who smoke, rather than if one views smoking, and therefore smokers, as a public health problem. I view tobacco products (and the manufacturers of those products) as the problem, not the act of smoking those products, and certainly not the smoker (the majority of whom we know are addicted to the product).

This is the perspective I bring to bear in analyzing public policies regarding the regulation of smoking and tobacco products. In this light, employee policies that refuse to hire smokers, fire employed smokers, or impose excess charges on employees who are addicted to nicotine are not public health policies. They do not appear to me to be crafted in the interest of addressing the problem of tobacco products. Instead, they appear to me to be crafted in the interest of punishing smokers for a behavior that I as a physician know is a powerfully addictive one that is extremely difficult to stop. (Here I am referring to policies regarding smoking off-the-job; smoking in the workplace and/or on-the-job are appropriate areas of workplace policy, as are many aspects of lawful employee behavior).

Similarly, policies that use smokers as a way to fund programs that we as a society should be funding anyway do not appear to me to be crafted within the confines of purely public health interests. I think support for these policies is largely a political decision, in which public health organizations are using the economic benefits of an increased cigarette tax to the state to achieve a particular end. Since there is available an alternative policy that would achieve the same end but in a way that is not regressive and does not punish the most heavily addicted and often the poorest smokers, a decision to support the kinds of cigarette tax increases for which many public health groups are now advocating implies to me a rejection of the more sound (from a public health perspective) alternative.

I think our evaluation of these policies reflects more than just our specific views on the most immediately relevant concerns. It also reflects the overall paradigm with which we practice. The way in which we frame the problem has implications for how the public views the problem. While it may not seem that supporting policies such as Weyco's that fire smokers is relevant to the overall practice of tobacco control, I think that the public perception of our actions is an important result that must be considered. If our positions on issues tend to frame the problem as one of individual behavior, then that's the way the public will tend to view the problem as well. And that is going to eventually become an obstacle to the promotion of the most important and potentially most effective tobacco control policies.

An article in the April issue of Radiology reports the results of a study of the use of helical CT scanning as an approach for the early detection of lung cancer among high risk smokers (Swensen SJ, Jett JR, Hartman TE, et al. CT screening for lung cancer: five-year prospective experience. Radiology 2005; 235:259-265). A group of 1,520 adults ages 50+ was followed for four years, receiving a baseline chest CT scan and four annual follow-up CT scans. The purpose of the study was to determine whether this approach would save lives by detecting lung cancers earlier than they would otherwise be detected, allowing for earlier and more effective treatment.

The study found that CT scan screening did not significantly reduce lung cancer deaths. Nor did it result in a shift to the detection of more very early cancers. But this screening did create problems for patients because of a very high false positive rate. False positive tests mean the finding of a lung nodule on the CT scan that turns out not to be cancerous. About three-fourths of the patients had a lung nodule detected, and of these, only 4% turned out to have cancer. Thus, well over 1,000 cancer-free patients were told they had a lung nodule suspicious for cancer and had to have further diagnostic procedures, sometimes involving surgical or other procedures (i.e., biopsy).

The Rest of the Story

While chest CT scan screening of current and ex-smokers at high risk for lung cancer turned out not to have any benefit to them, it did cause significant morbidity and mental distress. Being told that one has a nodule that could be cancerous tends to create substantial anxiety. For many of these patients, they had to live with this unnecessary anxiety for six months or even a year before they were able to be told that there was nothing to worry about. For others, they had to undergo further diagnostic tests, sometimes surgery.

Even among patients with new lung nodules greater than 4mm in size detected (nodules that were not present on the initial CT scan), the false positive rate was 92%. This means that the overwhelming majority of patients with newly diagnosed lung nodules (92%) did not have lung cancer.

Because of the anxiety produced by being told that one has a potentially cancerous lung nodule as well as the significant morbidity (and even mortality) associated with some of the interventions used to definitively diagnose these nodules, this study reveals that the CT screening approach resulted in more harm than good for these patients.

In order for a screening test to be effective for a relatively uncommon disease (and lung cancer is still uncommon, even in high risk smokers), the false positive rate must be extremely low. In other words, the test must not detect a large number of nodules that turn out to be benign. Otherwise, these patients will suffer a great deal of unnecessary anxiety and possibly morbidity and mortality. There would certainly have to be strong evidence of a significant mortality benefit in the population to recommend the use of such a screening test. In this case, helical CT scanning simply does not meet these criteria.

In more general terms, the results of this study underscore the pointlessness of devoting substantial resources to lung cancer screening. We should be focusing our resources in the area where we know we can have an effect: prevention of lung cancer through interventions to prevent smoking initiation and encourage smoking cessation.

A central tenet of medicine is "first, to do no harm." Screening for lung cancer, even in high risk individuals, appears to violate this basic principle.

Friday, March 25, 2005

In a web site report that was shared with individual tobacco control advocates this week, the Campaign for Tobacco-Free Kids argues that FDA performance standards proposed in the FDA tobacco legislation re-introduced in Congress last Thursday would make cigarettes less harmful. These performance standards refer to authority that would be given to FDA to require tobacco manufacturers to reduce or eliminate certain tobacco product ingredients or smoke constituents. The report went on to explain that these performance standards are in fact the primary way by which this legislation would make tobacco products less harmful.

According to the report: "These bills provide FDA with the authority to require changes to tobacco products to protect the public health, such as the reduction or elimination of ingredients, additives, and constituents, including smoke constituents ... A performance standard would be the primary way in which FDA would require tobacco products to be made less harmful."

The Rest of the Story

While on first impression, these performance standards might sound like a reasonable idea, closer inspection reveals that the idea is actually quite absurd. If tobacco smoke contained one or perhaps a few carcinogens, then it would make sense to attempt to regulate the safety of the product by setting standards for the presence of, or levels of, these carcinogens. But with over 40 known carcinogens, what sense is there in proposing to regulate the safety of the product by setting performance standards that would eliminate or reduce levels of just a number of these carcinogens? And what evidence is there to support an assertion that getting rid of a few of these carcinogens would make any significant difference in reducing the overall harm of the product?

Unfortunately, we simply do not know which specific carcinogens of the 40+ carcinogens in tobacco smoke and which specific toxins of the 4000+ chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemicals will be, as well as how the combination of chemicals removed will affect disease risk, if at all, and whether the processes used to alter the chemical makeup of cigarette smoke will introduce new chemicals that may even be more hazardous to health. There is absolutely no evidence to support a contention that requiring removal of a few selected substances in tobacco products would substantially reduce the health risks of smoking. Thus, any claim of public health relevance of such a requirement is completely unsubstantiated.

It should be clear how absurd this strategy for regulating the safety of cigarettes is from a public health perspective. To me, it seems misleading for public health groups to give the public the perception that performance standards will somehow make cigarettes a safer product. After all, these same public health groups are protesting the use of words like "mild" and "light" by cigarette companies, claiming that smokers are being misled into thinking that such cigarettes are safer. If public health practitioners are truly concerned about the adverse impact of unsubstantiated health claims, then they should certainly not be making any health claims that they cannot substantiate themselves. And the claim that performance standards "are in fact the primary way by which this legislation would make tobacco products less harmful" seems to me to be misleading, based on the above analysis.

Along similar lines, the health groups are touting that the legislation's requirement that cigarette companies disclose the complete list of ingredients, additives, and constituents in tobacco smoke would be an important public health victory. Given the complex nature of tobacco smoke, I doubt that such a requirement could be met, short of years and years of laboratory work. Nevertheless, even if it could be met, it has no relation whatsoever to the health of the public. What else do we need to know beyond the fact that cigarettes are deadly? Having a complete list of the thousands (and according to the National Cancer Institute, there may be hundreds of thousands) of smoke constituents is not going to help make tobacco products safer.

It seems to me that the effort to try to regulate the safety of tobacco products through an ingredient-by-ingredient approach is absurd, senseless, and a complete waste of resources. We simply cannot regulate the safety of this particular product, and we should not try to do so. Shouldn't we be concentrating our efforts on trying to get people to quit smoking and preventing them from starting to smoke, rather then pretending that the Food and Drug Administration will, in its infinite wisdom, be able to give companies a list and magically produce a safer cigarette?

I certainly hope that there are enough sensible public health advocates out there who realize how absurd this FDA tobacco legislation is. It would be a disaster for public health, and more specifically - a disaster for smokers, who would be grossly misled by the impression that the product is going to become safer, if this legislation were to be enacted.

Wednesday, March 23, 2005

Washington Governor Christine Gregoire has proposed a 20 cent per pack increase in the state cigarette excise tax, with a 60 cent per pack increase to follow in January 2007, in order to fund an initiative that would reduce school class size and create more student slots in state colleges, according to an article in Tuesday's Seattle Post-Intelligencer. Washington currently has the ninth-highest cigarette tax in the nation. According to the article, 11 other states are considering cigarette tax increases during the current legislative session. Public health advocates are generally among those who support these cigarette tax proposals. For example, in Texas, health advocates were the ones cited in a recent article as pushing for a tobacco tax increase, which would "help stretch the thin state budget."

The promotion of cigarette tax increases as a part of tobacco control practice started with the highly successful Proposition 99 in California, an initiative that increased the cigarette tax by 25 cents per pack and allocated 25% of the revenues to tobacco prevention and education programs, tobacco research, and smoking cessation programs (an approach that was followed in Massachusetts, Arizona, and Oregon). More recently, however, tobacco control and public health organizations have begun to promote cigarette tax increases to fund non-tobacco-related programs; this year, many of the tax increases that health advocates are supporting are being proposed to make up for general state budget shortfalls or to fund completely non-health-related programs that have been cut due to these budget shortfalls.

The Rest of the Story

While initially an advocate for cigarette tax increases as a public health and tobacco control strategy, I have come to change my position and I no longer view these tax increases as an appropriate public health approach unless the revenue (at least a significant portion of it) is used in a way that directly benefits smokers. I just cannot see a public health justification for using smokers as a way to raise revenues to fund programs that the government should otherwise be funding from general revenues.

In other words, if public health practitioners are faced with a decision about how to promote the funding of necessary and worthwhile health programs, then a justified approach would be to encourage policy makers to allocate funds towards those programs. That may mean arguing that these programs are more of a priority than some other currently funded programs or it may mean arguing for some new source of revenue. But it does not seem appropriate to repeatedly call on smokers to be the ones to share the burden of funding all of these programs that are not being funded adequately.

When cigarette taxes are raised substantially without allocating a portion of the funds to directly benefit smokers, then I believe those taxes are regressive. Because of the strength of nicotine addiction, it is a fact that the costs of the funded programs will be borne by smokers. If we in tobacco control are correct in our assertion that nicotine is powerfully addictive, then the reality is that smoking does not represent a choice that people make that they can quickly and easily change. So there is no way to avoid the consequence that for the large majority of smokers (who are going to be unable to quit), they will be paying the increased costs that are necessary to fund programs that should have already been funded by other means.

I find the situation quite different when the purpose of the tax increase is to provide funding that, in some way, benefits smokers directly. I think it can be effectively argued that providing smoking prevention programs as well as services to encourage smokers to quit and help them to succeed represents a direct benefit to smokers. After all, any smoker could potentially take advantage of the services being made available to them and it is reasonably in the interest of any smoker to encourage future generations to avoid this addiction. In this case, while smokers are being asked to shoulder the burden of funding certain programs, at least they are directly benefiting from the increased costs. The direct benefits of the policy accrue to both smokers and nonsmokers.

But the kind of tax increases for which public health and tobacco control advocates are currently lobbying are in most cases aimed at building roads and bridges, providing health services, paying for education, or funding a host of programs and services that the government should arguably be providing already. There are no direct benefits to the overwhelming majority of heavily addicted smokers who will not quit due to the cigarette tax, yet they are the ones shouldering nearly the full burden of the costs. I do not think it unreasonable to ask that public health practitioners insist that at least a portion of the resulting revenues be used for programs that will directly benefit the smokers who are providing the essential funds.

There are two other problems with promoting cigarette taxes as a way to raise general revenues or fund non-tobacco-related programs. First, if public health practitioners support this approach then it seems that they should similarly support taxation on other products that represent unhealthy behaviors, such as drinking alcohol, eating lots of fast food, or driving an SUV (which I believe increases mortality in motor vehicle accidents). However, I have not heard any tobacco control or public health organization lobby for an increased tax on alcohol, fast food products, or extremely large automobiles (or any other "unhealthy" consumer product) in order to fund much-needed government programs. If the argument for levying a tax on fast food products in order to decrease school class size sounds weak, then I can't see why an argument for levying a tax on cigarettes for the same purpose is a strong one.

Second, when cigarette tax revenues are used to fund specific programs or to make up for budget shortfalls, the state then becomes reliant upon cigarette consumption to maintain these programs and services. It creates, instantaneously, an inherent incentive for the government not to be successful in sharply reducing smoking. The long term impact of this reliance on sustained smoking as an essential source of revenue may well negate the positive short-term effect of the tax on reducing cigarette consumption. I don't see this as a problem when the revenue is being allocated specifically to establish well-funded tobacco prevention and cessation programs, because the incentive to maintain smoking prevalence is moot - the state has already funded what should be an effective program to reduce cigarette consumption. But in the absence of such a program, the reliance on cigarette revenues will make it infinitely more difficult for health advocates to ever succeed in convincing legislators to fund a program that, if it works, will substantially reduce funding for other state programs.

While the successful cigarette tax-funded tobacco control programs such as those in California and Massachusetts should serve as models for public health and tobacco control practitioners, the deterioration of this policy approach into an all-out attempt to raise cigarette taxes as a source of revenue for any program under the sun is, I think, unfortunate, unfair to addicted smokers, and unjustified on public health grounds.

Tuesday, March 22, 2005

The FDA tobacco legislation introduced in Congress Thursday, which is supported by Philip Morris and the Campaign for Tobacco-Free Kids, contains an escape clause that would allow Philip Morris or any other tobacco company to appeal to Congress to overturn any major regulation that the company does not like. The legislation explicitly gives Congress the ability to review and, by majority vote, to overturn, within 60 days, any major tobacco rules promulgated by FDA, resulting in such rule having no force or effect.

Given the lobbying power of Big Tobacco in Congress, this essentially gives the companies the ability to block any substantial tobacco rules that would be expected to have significant financial consequences -- precisely those which might otherwise have public health benefit. The legislation makes it easier for Big Tobacco to obtain a Congressional override of an FDA rule by prescribing rules for the consideration of such override legislation that limit the ability of legislators who oppose such a measure to kill it (i.e., it prescribes rules that take away many of the procedural moves by which legislation can normally be killed).

The Rest of the Story

By keeping all major regulatory decisions within the oversight of Congress, the legislation politicizes what should be primarily scientific and public health issues. This provision in the legislation essentially represents an "escape clause" by which the tobacco companies could escape unfavorable regulation simply by mobilizing enough support within Congress to pass a joint resolution of rule disapproval. And the rules governing the procedure by which such a joint resolution is considered are geared towards making it more difficult than normal to kill such a measure.

The bill achieves this escape for Big Tobacco by making any major FDA rules subject to section 801 of Title 5 of the United States Code (Congressional review of agency rulemaking). However, the bill could presumably have exempted these regulations from Congressional review just as easily. In fact, the bill does exempt from Congressional review the advertising and youth access regulations that the Secretary of Health and Human Services would be forced to promulgate (the 1996 FDA regulations). However, the remainder of the rules that FDA is given the authority to promulgate are not exempted from the Title 5, Section 801 provisions.

Presumably, the simple inclusion in the legislation of a clause stating that ‘‘Section 801 of Title V of the United States Code does not apply to the regulations referred to in the Family Smoking Prevention and Tobacco Control Act" would allow FDA to regulate tobacco products without explicit Congressional review and would eliminate the short-circuited process by which Congress can override FDA rules under the current bill.

That the Campaign for Tobacco-Free Kids has stated that this legislation is "strong" and puts "protection of the public health first" is unfortunate, given their presumable knowledge that this "Philip Morris escape clause" was tucked away into the bill, apparently with the Campaign's approval.

The Milwaukee-based Northwestern Mutual Life Insurance Company has announced that starting next year, it will impose a $25 per month health insurance coverage surcharge on employees who smoke - whether they smoke at work or at home, according to an article in the Milwaukee Journal Sentinel. Apparently, the surcharge will apply not only if the employee smokes, but also if a covered family member smokes. The article cites a Northwestern Mutual spokeswoman as saying: "We are not seeing this as a punishment in any way. We're just looking at different ways to incentivize people."

This announcement comes in the wake of Okemos, Michigan-based Weyco, Inc.'s decision to fire four employees who continued to smoke after a new policy requiring employees to quit smoking went into effect this past January. The policy makes it a firing offense for employees to smoke, whether they smoke at work or at home. The policy was announced one year in advance and smokers were offered cessation classes. Most of the smokers apparently quit, but four who did not were fired. A Lansing State Journal article quoted Weyco owner Howard Weyers as explaining that: "You can do whatever you want, but if you're going to work here, you can't be a smoker, like you can't be a drug user."

A third approach, in addition to firing smokers or imposing health insurance surcharges, that seems to be increasingly used by employers, reportedly in an effort to control health-realted expenses, is the refusal to hire smokers in the first place. For example, Union Pacific Corporation apparently instituted a pilot program in which it rejects the application of any prospective employee who indicates that he or she smokes.

The Rest of the Story

The actions of Weyco, Inc., Northwestern Mutual Life, Union Pacific Corporation, and other companies raises a question that is broader and perhaps more important than the question of employment policies regarding smokers: Is it appropriate for an employer to interfere in the legal, off-duty, private activities and lifestyle decisions of workers? There is little question that an employer has a legitimate interest in controlling behavior of its employees on-the-job. For many reasons, smoking while at work may be viewed as interfering with the performance of one's duties, may impose excess maintenance and cleaning costs, and may violate building smoking policies. However, there does not seem to be a legitimate employer interest in controlling employee's lawful activities off the job, or at least certainly not an interest so substantial that it would justify the degree of intrusion into an employee's private life that these policies represent.

These policies regarding smoking raise the question of what other life decisions employers will try to control next. Will they start imposing surcharges on, refusing to hire, or firing workers who are overweight, eat a lot of fast food, or fail to get enough physical activity? The argument that these smoking policies are simply an effort to "incentivize" workers does not hold water. So would a policy to require employees to lose weight, eat nutritious food, or engage in a certain amount of physical activity. And the comparison between smoking and drug use that the Weyco owner made is not relevant, since smoking is a legal activity; no one would argue that an employer should not be able to make employment decisions based on criminal behavior on the part of their workers.

As courts have thus far upheld employers' rights to use smoking as a factor in hiring decisions, some states have enacted laws that specifically disallow companies to refuse to hire smokers. But perhaps these laws are tailored too narrowly. Should the law not reflect the value that society places on freedom to engage in lawful activities and have autonomy of personal decision-making (as long as one does not engage in illegal behavior) outside of the workplace? Should such laws not simply state that lawful activities performed outside the workplace are not in the realm of factors that can be considered in employment decisions?

Regardless of the legal issues raised by these smoking employment policies, it is important to recognize that from a public health and tobacco control standpoint, there is no justification for promoting these policies, which represent an infringement on the autonomy of individuals to make lifestyle choices outside of the workplace, even if they may be unhealthy choices.

UPDATE (March 25, 10:00 am): For a published debate over this issue, see the April 2005 issue of Tobacco Control: Gray NJ. The case for smoker-free workplaces. Tobacco Control 2005; 14: 143-144 and Chapman S. The smoker-free workplace: the case against. Tobacco Control 2005; 14: 144.

It requires FDA to ban any tobacco product that contains a severely harmful chemical defect, but explicitly prevents FDA from doing the same with tobacco products that contain thousands of severely harmful chemicals, so long as those chemicals are ordinarily contained in tobacco products.

It provides for stringent regulation to prevent adulterated or misbranded products, but leaves the "pure" and "properly branded" deadly products largely unregulated.

It requires that manufacturers report any adverse health effects of its products that are unexpected, but the expected 400,000 or so deaths per year due to these products require no special attention.

It expresses grave concern for the tremendous harm to the public health caused by tobacco products that falsely purport to reduce disease risk, but does not require that FDA do anything about the high-dose products.

It strictly regulates new tobacco products introduced to the market for safety and health, but allows existing products to continue killing hundreds of thousands of Americans each year (there is no requirement that FDA do anything to regulate existing products).

It allows FDA to reduce or eliminate specific smoke constituents, but no one knows which constituents and in what combination and amounts are responsible for disease, nor does anyone know whether reducing or eliminating some of these constituents would have any effect whatsoever on health.

It expresses grave concern over youth access to tobacco products and calls for comprehensive restrictions on the sale of tobacco products to minors, but it explicitly prevents FDA from regulating the sale of cigarettes in any specific retail establishments (including malls, grocery stores, restaurants, gas stations, convenience stores, bowling alleys, and even pharmacies).

It provides for extremely rigorous and comprehensive (and probably impossible) tobacco company reporting of brand-specific levels of tobacco smoke constituents, but does not require any particular action concerning the many constituents that are already known to be harmful.

It requires the FDA to prescribe labeling requirements for the proper use of the tobacco product. How does one properly inhale dangerous chemicals and deadly carcinogens?

It requires FDA to consider periodically new medical data on cigarette risks, but the existing evidence on the established risks of cigarettes can be largely ignored.

It requires notification to all tobacco product users of the substantial health risks of any new tobacco products, but no special notification procedures for the existing deadly products.

It requires FDA to recall and ban any tobacco product that contains a manufacturing defect that is not ordinarily present in tobacco products, but a serious defect - such as producing death - is fine, so long as the deaths are caused by an ordinary constituent of the product rather than a new manufacturing defect.

It allows the FDA to prescribe strict regulations to protect the public's health from sub-standard packing and storage, but the fact that what is being packed and stored is inherently dangerous is of little concern. The FDA may prescribe stringent regulations to eliminate any pesticide residues on the tobacco, but the rest of the toxins inside the tobacco are not necessarily regulated.

It essentially ensures that true reduced risk products never enter the market, and that existing high-risk products never leave it.

It explicitly gives Congress the authority to immediately review and overturn any FDA-promulgated regulations that it does not like.

The Campaign for Tobacco-Free Kids' concluded that: "The language is carefully crafted to curtail abuse and to ensure the FDA has the broad authority over tobacco products it needs to protect public health and save lives."

I think a more accurate conclusion regarding the legislation would be: "The language is carefully crafted to limit FDA's authority in order to protect Philip Morris and its profits."

Saturday, March 19, 2005

In a statement posted on Globalink Thursday, the American Legacy Foundation defended its award to Time Inc. for "progress in tobacco-free publications" (see previous post and update).

The first paragraph of the response stated: "The American Legacy Foundation has for several months been aware of the concerns expressed by some members of the tobacco control and public health communities regarding the selection of Time Inc., as a recipient of the 2005 Progress in Media award at our annual American Legacy Foundation Honors event. This award for progress is just that: an award to encourage progress, not reward success. The foundation also presents three other awards: one each for public service, community activism and corporate leadership. ... Some awards honor leadership, others encourage progress, and others are based on research and activist leadership."

The response also attacked the author of this blog, accusing him of joining forces with the tobacco industry:

"So to those critics who believe we have 'exited tobacco control,' we disagree. And we note with interest that they have oddly joined forces with their enemies in the tobacco industry, who share their fervor for eliminating our organization."

The Rest of the Story

The American Legacy Foundation's response to criticism of its award to Time Inc. is, in many ways, even more problematic than the actual award.

The primary response of the Foundation was that the award was not an award to "reward success" but to "encourage progress." What a bunch of crap!

First of all, the verb award is defined as "to give as due or merited" (Random House Dictionary of the English Language). Thus, it implies that the recipient has done something to deserve the award. The Legacy Foundation can define the word, after the fact, however they may please, but the clear meaning of the award, as it is going to be interpreted by the public, is that Time, Inc. is being recognized for some sort of merit in tobacco control. In fact, the invitation to the awards dinner explains in some detail the "accomplishments" for which Time Inc. was being recognized.

Second of all, nowhere in the invitation to the awards dinner was there any implication that Time Inc. was being awarded solely to encourage them to make progress, rather than to recognize them for making progress. The invitation itself stated that the award was being given for "progress in tobacco-free publications" and for "reaching millions with an anti-tobacco message." The very name of the award - "Progress in Media" - makes it very clear that the award is recognizing progress.

Third, the very idea of giving an award to "encourage progress" is absurd. In 20 years in tobacco control and public health, I've never seen a public health group give an award to an organization that has done significant harm to the public's health solely to encourage progress. Generally, those of us in public health try to change harmful corporate behavior by criticizing that behavior, not by rewarding it.

If the American Legacy Foundation really wants to give an award to "encourage progress," why don't they simply give an award directly to Philip Morris? After all, if they want to encourage progress, the best place to start would be directly at the source.

What is most disturbing about the American Legacy Foundation's response is that they apparently have the audacity to believe that we - individual practitioners in tobacco control - are stupid enough to buy the explanation that they gave the award not to reward progress, but simply to encourage it. How stupid do they think we are? Even my children understand that when they they are awarded for something, they are being rewarded for an accomplishment of some sort, not that they are being told that we're unhappy with their behavior and want them to change - so here's a reward.

Instead of publicly issuing such a stupid response, why couldn't the Foundation simply admit their mistake and apologize? That's all that's required. No fancy explanations, no strange re-definitions of unambiguous, well-recognized words. Just a simple admission of a mistake, and a simple apology.

Finally, I cannot allow the Legacy Foundation's accusation that I have "oddly joined forces with [my] enemies in the tobacco industry" to go unmentioned. The statement is a pure lie - I have not joined forces with the tobacco industry and they know it. So does everyone in tobacco control.

Nevertheless, the Legacy Foundation's statement accusing me of joining forces with the tobacco industry is not most disturbing to me because it is an untruthful personal attack. It is most disturbing to me because it suggests that their view is that anyone within public health who criticizes their actions must be working with the tobacco industry. They apparently view their "truth" campaign as so sacred, and so important, that anything anyone says that may in any way interfere with Legacy's efforts to secure funding for that campaign, even if such efforts are viewed as being inappropriate, is tantamount to helping out the tobacco industry.

Actually, by having the courage to speak out and help ensure that the means by which public health practitioners achieve their desired ends are ethical, appropriate, justified, truthful, and carried out with integrity, we are helping to strengthen and improve the public health movement, not the tobacco industry.

Thursday, March 17, 2005

The nation's largest tobacco company and four prominent health groups today joined together to support legislation that would give the FDA authority to regulate tobacco products. In statements issued today, Philip Morris USA (web site) and a coalition of the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Heart Association and the American Lung Association (press release) expressed support for bills introduced today concurrently in the Senate and the House. The Altria web site provided a link to the Campaign for Tobacco-Free Kids press release, emphasizing the nexus between the tobacco manufacturer and some members of the public health community on this issue. Philip Morris also noted that it has "worked diligently with the public health community" in reaching this "policy solution."

Among the bill's provisions cited by both Philip Morris and the coalition of health groups as benefiting the public's health are strengthened cigarette warning labels, full ingredient disclosure, authority for FDA to eliminate terms like "light" and "low-tar," authority for FDA to require removal of certain harmful tobacco smoke components, a ban on candy and fruit flavored cigarettes, and authority for FDA to help prevent the sale of tobacco to minors.

The Rest of the StoryBased on a detailed analysis of the specific provisions of the legislation, it is clear that it fails to protect the public’s health in any substantial way, and that in fact, it would be detrimental to the public’s health in a number of ways:

The way in which the bill frames the problem of tobacco use in our society is inconsistent with the public health paradigm. The bill stringently regulates new products and reduced risk products, but essentially allows existing, high-risk products to continue killing hundreds of thousands of Americans each year.

The bill completely ties the hands of FDA in terms of complying with the very legislation that sets requirements for its action. The loopholes in the legislation are huge, and not only benefit the tobacco industry, but institutionalize tobacco and addiction to tobacco products in our society. The fatal flaw of the legislation is the unacceptable degree of restriction of FDA’s potential actions which makes it impossible for FDA to act appropriately within the legislative mandate it is given.

Tobacco companies will benefit from this bill because they will be able to use the fact of being regulated by FDA to achieve improved public opinion by taking advantage of the public perception that the tobacco problem is basically taken care of. The public’s perceived level of the health risk posed by ordinary tobacco products will decline as the public perceives the fact of FDA regulation as automatically meaning that the product must be reasonably safe, or at least safer. The bill will likely result in increased deaths compared to no legislation at all, as the bill will:

make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products;

undermine current and future litigation and the public health remedies that are likely to result from such litigation, as tobacco companies will be able to successfully use the argument that they are already thoroughly regulated; and

reduce the public's perception of the inherent harms of cigarettes.

Additionally, there are no documented mechanisms by which the legislation will save lives:

Research has documented that the kinds of marketing restrictions imposed by the bill are not effective in reducing youth smoking, or even in reducing youth exposure to cigarette advertising. The more stringent of the advertising restrictions will certainly be challenged in court, and may be found to violate the First Amendment.

Performance standards and disclosure requirements of the bill will not improve the public’s health. It is simply not known which specific carcinogens of the 40+ carcinogens in tobacco smoke and which specific toxins of the 4000+ chemicals in tobacco smoke are responsible for what diseases, what quantities of these chemicals produce what effect, and what the effect of removing these chemicals will be.

The Modified Risk Product section of the bill would make it virtually impossible for modified risk products to enter the market, while at the same time, allowing reduced exposure products to essentially be falsely marketed as reduced risk products. In effect, it protects the existing high-risk products on the market and precludes any harm reduction approach to tobacco control.

The basic approach taken by the legislation is quite absurd from a public health perspective:

The measure would stringently regulate new and potentially less hazardous tobacco products while doing little to prevent the most harmful form of tobacco – existing cigarettes – from continuing to cause the deaths of nearly half a million Americans each year.

Although the bill would enable the FDA to prevent the introduction of new cigarette brands that falsely claim to reduce the risk of disease, it would permit Marlboro and the other most popular existing cigarette brands to continue business as usual.

The bill bans the use of strawberry, grape, chocolate, or similar flavoring additives in cigarettes but does not mandate the elimination (or even reduction) of toxic gases like hydrogen cyanide or the more than 40 known cancer-causing constituents of cigarette smoke such as benz(a)pyrene, benzene, and radioactive polonium.

Philip Morris now stands shoulder to shoulder with the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Heart Association, and the American Lung Association in lobbying for passage of this legislation. Even if a detailed analysis of the bill did not reveal the reasons why Philip Morris supports the legislation, one would have to question the judgment of the health groups in helping the leading tobacco company achieve the federal policy result it most desires.

If this bill passes, it will be devastating for the tobacco control movement as well as for the public's health.

Wednesday, March 16, 2005

A little-noticed New York federal district court decision issued in September has brought to the forefront how strongly the nation's attorneys general, including the current treasurer of the American Legacy Foundation, have worked to protect the interests of the nation's leading tobacco companies.

In the case, plaintiffs (importers that buy from small tobacco manufacturers that did not participate in the Master Settlement Agreement [MSA]) assert that the MSA and certain state laws related to MSA provisions violate antitrust laws because they have created an "output cartel" by the major tobacco companies that unfairly and illegally inhibits competition from smaller companies. In January 2004, a New York federal appeals court ruled that the MSA could indeed be challenged on antitrust grounds.

Now, a New York district court judge has issued an injunction against the state law, effective in 2003, that essentially forces non-participating tobacco companies to make full MSA payments to all states, even if they sell in only one or a few states. The injunction finds that this law, which is similar to laws passed in 38 other states, is not justified on any public health or other basis and is likely to violate antitrust laws. The judge found that: "The only purpose [of the law] appears to be a desire to accommodate the PMs [participating manufacturers - i.e., big tobacco companies], and to protect them unduly against competition from the NPMs [non-participating manufacturers - i.e., small tobacco companies]."

The Rest of the Story

The MSA represents, and has created, a strong partnership between the state attorneys general and the major tobacco companies. This partnership is evidenced by the extent to which the AGs have gone to protect Big Tobacco from harm:

The MSA itself imposed escrow payments by non-participating manufacturers -- companies that were not even parties to the agreement -- by requiring states to pass such laws in order to receive their full share of MSA payments.

The MSA made payments to the Public Education Fund contingent on the large tobacco companies retaining their overwhelming market share.

Most of the attorneys general joined in the submission of an amicus brief in the Price vs. Philip Morris case in Illinois, urging the judge to reduce the $12 billion bond payment that he had required of the company after his Madison County trial court issued a $10.1 billion judgment against Philip Morris (see separate posting on the amicus brief). Signatories included William Sorrell (Vermont), now treasurer of the American Legacy Foundation and Christine Gregoire (Washington), former board chair of the American Legacy Foundation.

It appears that at least some of the attorneys general (most notably, Bob Butterworth of Florida [which settled its tobacco lawsuit independently with the companies]) played a role in supporting state legislation (enacted in at least 23 states) that places limits on the amount of the appeal bond that tobacco companies must pay in order to challenge a guilty verdict.

According to a recent Fortune article (Roger Parloff, Is the $200 billion tobacco deal going up in smoke? March 7, 2005), Attorney General William Sorrell of Vermont wrote a letter to all state attorneys general in September 2003 warning them that the success of non-participating tobacco companies was threatening the market share of Big Tobacco and urging them to take action to protect Big Tobacco from this competition: "Increasing sales by [nonparticipating manufacturers] will sharply reduce the next scheduled payments. These results underscore the urgency of all states taking steps to deal with the proliferation of [nonparticipant] sales."

The MSA has in fact set up a partnership between the states and the tobacco companies, and the attorneys general have gone to great lengths to come to the financial rescue of Big Tobacco in order to protect both of their financial interests. The financial interests of the states and Big Tobacco are irretrievably intertwined because of the MSA.

Despite anything that the attorneys general or their public anti-smoking foundation - the American Legacy Foundation - may say about the public health benefits of the settlement, the alliance that it has created between the states and Big Tobacco is a complete public health disaster that dwarfs any small positive impact that the MSA may have had on the public's health.

In my view, the MSA and what it has created - including the actions of the nation's attorneys general and the American Legacy Foundation, which have undermined public health goals for financial interests - is and will continue to be the greatest public health blunder of my lifetime.

UPDATE (March 16, 10:30 pm): The New York state Senate today passed a bill that would cap at $100 million the bond tobacco companies would have to post in order to appeal a damage award against them. According to a Newsday article, a spokesman for Governor Pataki confirmed that the reason for this bill was to protect the state's MSA payments (in other words, to protect the financial health of Philip Morris). This is just the latest example of the public health damage created by the partnership between the states and the tobacco companies.

UPDATE 2 (March 20, 10:30 am): A Louisville Courier-Journal article reported yesterday that a federal district judge this week issued an injunction against part of a 2004 Kentucky law that essentially forces non-participating tobacco companies to make full MSA payments to all states, even if they sell in only one or a few states. This now marks the second instance in which an injunction has been issued againstan MSA-related state law intended to protect Big Tobacco from smaller potential competing manufacturers. A federal judicial panel is considering whether to consolidate related cases in New York, Kentucky, Oklahoma, Tennessee and move them all to the New York court.

UPDATE 3 (March 28, 4:15 pm): The Arkansas House passed a bill that would limit the bond tobacco companies would have to pay to appeal an unfavorable court decision to $25 million, regardless of the amount of the damages awarded. Under current law, the companies would have to post bond for the full amount of the damages in order to appeal the decision.

The American Legacy Foundation will be presenting an award in the name of Washington Governor Christine Gregoire at the 2005 National Tobacco Control Conference in Chicago. The award, entitled the Christine O. Gregoire Youth/Young Adult Award for Outstanding Use of Tobacco Industry Documents, "recognizes a person 24 years of age or younger who has made a contribution to the health of the public in the recent past through use of tobacco documents."

Gregoire, the former Attorney General of Washington, played a key role in the negotiation of the 1998 Master Settlement Agreement [MSA] between 46 states and the major tobacco companies. She is a former board chair of the American Legacy Foundation.

The Rest of the Story

In 2003, Gregoire (then Attorney General of Washington), along with other attorneys general, intervened in an Illinois tobacco court case, submitting an amicus brief to a trial court judge urging him to reduce the $12 billion appeal bond he had ordered Philip Morris to pay, as specified by Illinois law, after the company was found guilty in a class-action lawsuit.

In intervening to protect the financial well-being of Philip Morris, Gregoire wrote: "Defendant Philip Morris has informed the States that the $12 billion appeal bond required in this Court’s March 21, 2003 Judgment may prevent it from making the $2.6 billion payment to the States that the MSA requires it to make on April 15, 2003. The States submit this brief to advise the Court that many State programs, including vital public health programs, depend on MSA payments for their support and to urge this Court, after a full assessment of Defendant’s financial condition, to exercise its discretion to set an appeal bond that does not interfere with the States’ vital interests. ... The States have a strong interest in preserving the value of the settlements they fought for and won, and the results in this lawsuit should not prejudice those settlements."

In other words, Gregoire was arguing that because the legal remedy awarded to plaintiffs in Illinois - under the judicial system and laws of Illinois and under the United States Constitution - affected financial payments to her state, the judge should alter the application of Illinois law to protect her state's financial interests, and that concern should override the pursuit of justice by these citizens under the laws of Illinois.

It is baffling how any serious or meaningful award in tobacco control could be named after a public official who went to bat for Philip Morris, intervening and interfering in the pursuit of justice by a class of citizens in another state, all in an effort to protect the financial welfare of the nation's leading tobacco company (whose products, based on market share, kill more than 200,000 Americans each year).

Since the Feb. 28 ceremony at which the American Legacy Foundation honored Time Inc. for "progress in tobacco-free publications" and for "reaching millions with an anti-tobacco message" (see previous posting), here is an accounting of Time Inc.'s "contributions" to tobacco control:

In these 6 publications alone, and in just the 2 weeks since its Legacy award, Time Inc. has carried 12 pages of tobacco advertising, reaching at least 3 million youths. And ironically, on the same evening that Legacy was making the publisher of Sports Illustrated appear to have an anti-tobacco front, the back cover of Sports Illustrated was exposing million of youths to a full-page Camel ad featuring a young, macho-looking, attractive male smoking a cigarette with the caption "Pleasure to Burn."

Time Inc. certainly has the right to publish these ads and it is not my expectation that this publisher would unilaterally forsake tobacco ad revenues. Its goal is not supposed to be improving the public's health. Not so with the American Legacy Foundation. It is presumably a public health organization whose goal is to reduce youth smoking. Its award to Time Inc. undermines its overall mission and has the appearance of putting its own financial status ahead of the objectives of the tobacco control movement.

The American Legacy Foundation award was obviously a sham. Unfortunately, the damage that Legacy did to the credibility and integrity of the tobacco control movement by giving this award is quite real.

Thursday, March 10, 2005

Philip Morris is now test-marketing a new cigarette brand -- Marlboro Ultra Smooth -- which contains a new carbon filter that was presumably designed to help filter out certain toxins in cigarette smoke and to therefore reduce exposure to these toxins. The cigarettes are being test-marketed in Atlanta Tampa, and Salt Lake City. However, Philip Morris is explicitly not making any reduced risk or reduced exposure "health claims." According to a Wall Street Journal article, the company wrote in a Jan. 11 letter to the state attorneys general that it "will not make reduced exposure claims about Marlboro Ultra Smooth because we do not have evidence that the application of these new carbon filters warrants a reduced exposure claim."

Some public health advocates, including Matt Myers, president of the Campaign for Tobacco-Free Kids, are concerned that the marketing of this new brand will mislead the public into thinking that it offers some degree of health protection. In a Richmond Times-Dispatch article, Myers stated: "The critical fact is that the emphasis on 'ultrasmooth,' combined with the reference to a new filter is very likely to result in consumers believing that this is a safer product. Philip Morris doesn't have to make explicit claims to result in consumers being misled."

The Campaign for Tobacco-Free Kids, which last year joined Philip Morris in lobbying Congress for a bill that would give FDA authority to regulate tobacco products, argues that this FDA legislation is necessary to address the fact that smokers are being misled by terms like "light," "ultra-light" and "low-tar" in current cigarettes and could be misled by new "reduced risk" or potentially reduced exposure products (PREPS), like Marlboro Ultra Smooth. The Campaign will direct a session at the 2005 National Tobacco Control Conference in May to address what it states is a "critical need for FDA regulation."

The Rest of the Story

My analysis of the FDA bill considered last year reveals that it would substantially help, not hurt Philip Morris in marketing its Marlboro Ultra Smooth product (and other similar PREPS). Instead of simply having to rely on creative labeling to market the product, under the proposed FDA legislation, Philip Morris could explicitly promote the new brand as a "reduced exposure" cigarette that has been approved by the federal government.

Currently, Philip Morris is apparently reluctant, if not unwilling, to explicitly market Marlboro Ultra Smooth as a reduced exposure product, because it does not feel it has "evidence" to support such a claim and under the Master Settlement Agreement, state attorneys general are scrutinizing the new product and can sue the company if it makes "any material misrepresentation of fact regarding the health consequences of using any tobacco product, including any tobacco additives, filters, paper or other ingredients."

However, if the FDA legislation is enacted (in the form supported by the Campaign for Tobacco-Free Kids last session), Philip Morris could potentially market Marlboro Ultra Smooth as a "reduced exposure" product (explicitly representing to the public that the brand "presents a reduced exposure to a substance in tobacco smoke"). The main burden of proof to the company would be to show that:

(1) "scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth [in paragraph (1)]" (see Section 911(g)(2)(A)(iii)); and

(2) "the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies" (see Section 911(g)(2)(A)(iv)).

In other words, in the absence of any substantiated evidence of a reduced health risk, Philip Morris could essentially market a product as "reduced exposure" as long as it merely anticipates that a positive effect on health would be expected.

So ironically, the FDA legislation supported by the Campaign for Tobacco Free Kids and Philip Morris might actually put Philip Morris in the position of being able to make explicit reduced exposure claims that it cannot (or at least is unwilling to make) right now. This is most likely one of the major reasons why Philip Morris wants the FDA bill so badly.

By setting up a regulatory "permit" process for cigarettes for which a reduced exposure claim is made, the FDA legislation would explicitly force the federal government to permit such claims. This is the classic fallacy that underlies the actions of many public health groups that believe federal regulation is the answer to the problem of controlling corporate behavior.

Perhaps more importantly, as the Campaign for Tobacco-Free Kids readily admits (see quote above), Philip Morris doesn't have to actually make health claims to result in consumers being misled. If this is true, then requiring FDA approval only of those tobacco products whose marketing represents that they improve health or reduce exposure is not going to solve the problem.

The rest of the story reveals that although PREPS like Marlboro Ultra Smooth are problematic, the FDA legislation supported by Philip Morris and Tobacco-Free Kids will make the problem worse, not better: it will specifically permit reduced exposure claims to be made in the absence of substantiated evidence of reduced health risk -- exacerbating the very problem that the legislation is purported to solve.

Tuesday, March 08, 2005

In its Feb. 23 newsletter, Boston's Dana-Farber Cancer Institute (DFCI) announced the appointment of Bennett S. LeBow to its board of trustees. Founded in 1947, the Institute, which is one of the nation's foremost cancer research and treatment centers, describes its mission as providing "expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases."

The Feb. 23 newsletter describes Mr. LeBow as follows: "Bennett S. LeBow, a former computer analyst, founded Brooke Group in 1980 to acquire troubled companies and turn them around. Today this prominent businessman is one of the country’s leading philanthropists and has been a generous supporter of DFCI in a number of ways. In 2002 he established the LeBow Genomic/Genetic Research Fund, which supports research to identify and validate the genetic changes responsible for multiple myeloma development, disease progression, and emergence of resistance to conventional chemotherapeutic agents. Many of LeBow’s early investments were in the computer industry, and eventually expanded into other areas. He currently serves as director of the New Valley Corporation and as president of the Bennett & Geraldine LeBow Foundation."

The Rest of the StoryWhat the DFCI newsletter failed to reveal is that Bennett S. LeBow is not just any old "prominent businessman." He is the Chief Executive Officer of Vector Group Ltd., whose subsidiaries -- Liggett Group Inc. and Vector Tobacco Inc. -- produce more than 9.8 billion cigarettes each year, according to the 2003 Annual Report. Liggett is the sixth largest manufacturer of cigarettes in the United States, accounting for 2.6% of domestic cigarette production, and therefore (by extrapolation) resulting in more than 10,000 annual deaths, many of them from cancer.

And as if that isn't enough, according to Gene Borio's Tobacco on Trial blog, LeBow recently testified in federal court that "I’m hesitating on the direct link" between cigarette smoking and lung cancer. Moreover, a Florida jury found Liggett liable for damages in a class-action lawsuit on behalf of Florida smokers on grounds of " strict liability, negligence, breach of express warranty, breach of implied warranty, fraud, conspiracy to commit fraud, and intentional infliction of emotional distress." The jury assessed punitive damages of $790 million against LeBow's company, although the verdict has been appealed and a Florida Supreme Court decision is pending.

The appointment of LeBow to Dana-Farber's board of trustees is difficult to believe. How could one of the nation's premiere cancer research and treatment centers choose the CEO of a major tobacco company -- whose products are partly responsible for the suffering of its cancer patients -- to sit on its board of trustees? And the perception that DFCI intentionally overlooked his chairmanship of a top tobacco company because he made financial contributions to the Institute is troubling. But perhaps even more troubling is the Institute's failure to disclose LeBow's affiliation in its newsletter. Did it really think it could hide LeBow's true identity from its contributors?

Well apparently not, as an article in today's Boston Globe reported that LeBow has stepped down from his board position after the newspaper inquired about his appointment.

The rest of the story reveals not only a serious error in judgment on the part of a leading cancer institute but possibly an attempt to deceive contributors about the true nature of the board appointee -- all in the interest, it appears -- of rewarding a substantial benefactor.

Sunday, March 06, 2005

The Citizens' Commission to Protect the Truth -- a nonprofit organization created "to help ensure the continuation of truth®, the American Legacy Foundation's youth anti-smoking media campaign -- on February 24 submitted an amicus brief asking a federal District Court judge to order the tobacco company defendants in the Department of Justice's RICO-based lawsuit to "fund the Legacy's anti-tobacco truth® campaign to discourage smoking by children and teens." The brief argues that this would be an appropriate remedy in the case because it would "prevent future violations of RICO by the Defendant tobacco companies."

The Commission, which consists of all the living former Secretaries of Health, Education, and Welfare and Health and Human Services, Surgeon Generals, and CDC Directors, offered two primary arguments: (1) that an appropriate remedy for the tobacco company defendants' violations of the RICO statute is to order them "to fund a public education and youth smoking prevention campaign"; and (2) that "the American Legacy Foundation's truth® campaign should be the organization so funded." Two press releases were issued announcing the filing of this amicus brief. A Feb. 23 release states that the Citizens' Commission "was established to work toward the continued funding of the American Legacy Foundation's truth youth media campaign, which lost its funding in 2003." A Feb. 25 release states that the Citizens' Commission "was formed in 2004 to shine a spotlight on the continued need to fund truth and to require the major tobacco companies to continue financing the truth® campaign."

The Rest of the Story

What is not revealed in either the amicus brief or the press releases is the fact that the Citizens' Commission's primary source of funding is a grant from the American Legacy Foundation. According to the Commission's web site: "Principal funding for The Commission comes from the National Association of Attorneys General through a $1.5 million pass-through grant from the American Legacy Foundation." In other words, the American Legacy Foundation is funding a front group that has the appearance of being an independent entity that happens to support the Foundation's efforts, but which actually relies upon the Foundation as its chief source of funding.

At very least, this represents a significant conflict of interest that should certainly be disclosed in a legal brief submitted to a federal court judge in such an important and potentially far-reaching lawsuit. In legal terms, a conflict of interest occurs when one "has competing professional or personal obligations or personal or financial interests that would make it difficult to fulfill his duties fairly." It would be hard to imagine the Citizens' Commission being able to perform its duties for the Court (as a supposedly independent party intervening with a supposedly legal opinion) fairly in this matter, given that its primary funding comes from the American Legacy Foundation and that it could therefore not be expected to offer any opinion other than that Legacy should be the "organization so funded" to carry out any potential anti-smoking media campaign ordered as a remedy in the case.

At worst, this could represent a violation, by Legacy, of basic ethical standards of conduct expected to underlie the behavior of a public health organization. If it is true, as it appears based on its behavior, that Legacy's intent was to fund a group to have the appearance of an independent entity composed of a group of "citizens" so concerned about the importance of funding the truth® campaign without explicitly disclosing the true financial underpinnings of the organization, then this desperate attempt by Legacy to save its funding in light of dwindling resources from the tobacco companies represents a serious breach of ethical conduct.

For years, tobacco control advocates have complained about the tobacco industry's use of front groups -- local organizations that are funded primarily by the industry but which represent themselves as independent coalitions of concerned citizens -- to advance tobacco industry policy interests (examples: 12345). If the funding source for these front groups was disclosed, the groups would lose credibility and effectiveness as the conflict of interest in their opinions would be readily apparent.

Simply because we in public health are working toward a noble goal does not absolve us of the responsibility of acting ethically and with integrity. Using the same deceptive tactics that we criticize the tobacco industry for using is both hypocritical and wrong.

The simple funding of an organization to support one's own goals is not necessarily problematic. What is problematic is the deceptive intent. And that deceptive intent is suggested when the funded group fails to disclose the source of its funding. Failing to be forthright about its primary source of funding in press releases that will lead to news stories read by millions and in a federal court case in which the pursuit of justice is paramount appears to suggest deceptive intent. Adding to this impression is the failure to fully disclose its financial relationship with the American Legacy Foundation in the Commission's fact sheet, mission statement, a similar previous press release, and the press release announcing its formation, as well as on its current internet home page.

The rest of the story reveals deception on a grand scale by the very organization that seeks to convince a federal judge that it should be the organization chosen to run a national anti-smoking campaign under the name of the "truth."

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.